FDA.reportPublic FDA data

NDC 68308-784-01 - Isotretinoin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68308-784
Requested NDC
68308-784-01
Package NDCs from labels
68308-784-01, 68308-784-30
Manufacturer
Mayne Pharma
Effective date
2024-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isotretinoin - Mayne PharmaMayne Pharma2024-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68308-784-01Isotretinoin10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED104
68308-784-30Isotretinoin3 in 1 BOXCAPSULE, LIQUID FILLED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68308-784ISOTRETINOIN CAPSULE, LIQUID FILLED [MAYNE PHARMA]4Current NDC, 2 package rows20240628_0114567b-3bac-490d-b9eb-03a6c5d90935.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68308-784-01EA - Each68308-784462faae8-2883-4ab8-904e-aad7aa61654212024-01-04
68308-784-30EA - Each68308-784a238822f-acae-4f2f-8696-c46354a4b72d12024-01-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 58 of 298 · 5,946 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
70% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC106f51fa-e687-470f-8ed8-35cb0565aeff2026-03-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC4ab76d25-136d-45e2-b9d7-964777e1d8552026-03-11Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Alcohol Antiseptic PadsISOPROPYL ALCOHOLAcme United Corporation4cc307b9-aee2-3ce0-e063-6294a90aa1692026-03-11WarningsExact identifier
unii: ND2M416302
Hand Sanitizing WipesETHYL ALCOHOLUpLift Brands, LLCca7c6243-dc7f-40c4-8b51-ec9a7c1f14f52026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUpLift Brands, LLCba4be8c2-00ce-48e6-a83c-6c1bde3c3aa42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLUpLift Brands LLCf6608379-051f-4151-bcf7-ecd87070f4392026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCa1954926-35f6-439e-863f-29351013e5542026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands LLCdd569334-0280-49d6-afcf-0c49ed316cb92026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCef02b350-1a37-42d4-8eaa-38a2de5e41eb2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCbf53255d-18d7-4672-8139-bacc5cb1a2e62026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLC03ed8a06-33aa-4893-824c-a3843962de3d2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand Sanitizer with AloeETHYL ALCOHOLUpLift Brands, LLC62cfbf46-9c12-487f-81d9-a1f839402ec42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
ETHYL ALCOHOLETHYL ALCOHOLUpLift Brands, LLC42b1aff5-d788-0d46-e063-6294a90a02d32026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Whipped Vanilla CloudsALCOHOLBath & Body Works, Inc.46178c56-3e33-4523-e063-6394a90aca792026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blue Raspberry FreezeALCOHOLBath & Body Works, Inc.4616db35-113d-970f-e063-6394a90aa38d2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.4616f2ce-1b5e-436d-e063-6394a90acbe22026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sparkling WatermelonALCOHOLBath & Body Works, Inc.46156243-39d7-f56c-e063-6394a90a2d2c2026-03-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.